Validation Engineer / CQV Engineer

Job Summary:

• Support validation and commissioning/qualification/validation (CQV) activities onsite for sterile manufacturing and fill/finish operations.
• Execute hands-on OQ/PQ (Operational/Performance Qualification) protocols and equipment qualification in a GMP-regulated environment.
• Prepare and manage GMP documentation, including protocol execution, discrepancy/deviation resolution, and qualification deliverables.
• Work independently and efficiently in a fast-paced, project-driven setting.
• Perform validation activities for equipment such as autoclaves, formulation equipment, fill suites, high-velocity fillers, isolators, parts washers, tanks, and aseptic process systems.
• Contribute expertise to fill line qualification, aseptic filling, and sterile manufacturing processes.
• Provide support for vision systems or automated inspection systems, particularly for high-speed fill lines or aseptic production.
• Ensure accurate real-time documentation, and assist with protocol closeout and deviation management.
• Collaborate with cross-functional teams to ensure compliance and timely completion of validation tasks.
• Must be local and available for a hybrid onsite role.

• Education:

  Bachelor s degree in Engineering, Life Sciences, or related field preferred; equivalent hands-on validation/CQV experience in GMP environments considered.
• Strong plus: Experience with Kaye validators, wireless probes, SIP/VHP sterilization, vision/inspection systems, and comprehensive equipment qualification documentation.